Evolocumab is a Monoclonal Antibody owned by Amgen, and is involved in 82 clinical trials, of which 55 were completed, 21 are ongoing, and 6 are planned.
Evolocumab (AMG-145) bind to PCSK9 and inhibit PCSK9 from binding to LDL receptors on the liver surface. In the absence of PCSK9, there are more LDL receptors on the surface of the liver to remove LDL-C from the blood. In the hepatocyte, PCSK9 undergoes an obligatory autocatalytic cleavage in the endoplasmic reticulum before being secreted, but its catalytic activity is not required for its ability to modulate LDL-R surface expression. Rather, PCSK9 is secreted into plasma by hepatocytes and acts by binding to the LDL-R extracellularly, being internalized with it and facilitating its enhanced degradation. PCSK9 does not itself degrade the LDL-R but binds tightly to it and channels it toward the lysosomal compartment for degradation. Thus, it inhibits the recycling of the LDL-R back to the cell surface, which results in decreased LDL-R number. Blocking PCSK9 binding to the LDL-R can profoundly lower plasma LDL levels.
The revenue for Evolocumab is expected to reach a total of $30.9bn through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Evolocumab NPV Report.
Evolocumab (AMG-145, Repatha) is a monoclonal antibody acts as lipid modifying agent. It is formulated as injection solution for subcutaneous route of administration. Repatha is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of pediatrics, adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (CVD), who require additional lowering of low density lipoprotein cholesterol (LDL-C), as an adjunct to diet and other LDL-lowering therapies (e.g., statins, ezetimibe, LDL apheresis) for the treatment of pediatric and adult patients with homozygous familial hypercholesterolemia (HoFH) who require additional lowering of LDL-C, in adults with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia, as an adjunct to diet in combination with a statin or statin with other lipid lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or, alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated and also indicated in adults and adolescents aged 12 years and over with homozygous familial hypercholesterolemia in combination with other lipid-lowering therapies, also indicated to reduce the risk of myocardial infarction, stroke, coronary revascularization in adults with established cardiovascular disease, and for treating hypercholesterolemia patients who are not suitable for HMG-CoA reductase inhibitor (statin) therapy.
Evolocumab is under development for the treatment of homozygous familial hypercholesterolemia and heterozygous familial hypercholesterolemia (HeFH) in pediatrics and hypercholesterolemia.
Amgen is a biotechnology company, which discovers, develops, manufactures, and markets innovative human medicines to treat patients suffering from serious diseases. It develops novel medicines in six focused disease areas including cardiovascular diseases, oncology/hematology, inflammation, bone health, neurological disorders and nephrology. The company develops products using advanced human genetics to unravel the difficulties of disease and understand the fundamentals of human biology. Amgen sells products primarily to pharmaceutical wholesale distributors in the US. It also markets certain products directly to consumers through direct-to-consumer channels such as print, television and online media. Amgen is headquartered in Thousand Oaks, California, the US.
The company reported revenues of (US Dollars) US$25,979 million for the fiscal year ended December 2021 (FY2021), an increase of 2.2% over FY2020. In FY2021, the company’s operating margin was 29.4%, compared to an operating margin of 35.9% in FY2020. In FY2021, the company recorded a net margin of 22.7%, compared to a net margin of 28.6% in FY2020. The company reported revenues of US$6,652 million for the third quarter ended September 2022, an increase of 0.9% over the previous quarter.
Quick View – Evolocumab
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